Contraceptive system and method of use

ABSTRACT

A device and method of using the device for contraception or sterilization and particularly for reversible contraception by occluding a reproductive lumen to prevent the passage of reproductive cells through the lumen for a desired period of time until the patient wishes to become fertile again and then be reopened. The occluding member preferably comprises a tubular framework formed from a shape memory material configured to be implanted in a reproductive lumen. The occluding member is implanted within a body lumen, secured to the wall of the reproductive lumen and then collapsed to collapse the wall and occlude the lumen. Alternatively, the occluding member may be collapsed upon a solid plug. The closure of the reproductive lumen may be reversed by introducing a balloon catheter and by a series of inflations of the balloon reexpanding the collapsed occluding member or by removing the plug. The occluding member and the plug may be configured to facilitate endothelialization, to provoke an inflammatory responses or to deliver a drug.

This application is a continuation of application Ser. No. 10/272,840,filed on Oct. 16, 2002 now abandoned, which is a continuation ofapplication Ser. No. 08/770,123, now U.S. Pat. No. 7,073,504, filed onDec. 18, 1996, the entireties of which are hereby incorporated byreference.

FIELD OF INVENTION

This invention relates to the field of contraceptive and sterilizationdevices and more particularly to reversible contraceptive devices andthe methods of using such devices.

BACKGROUND OF THE INVENTION

Conventional contraceptive strategies generally fall within threecategories: physical barriers, drugs and surgery. While each havecertain advantages, they also suffer from various drawbacks. Barrierssuch as condoms and diaphragms are subject to failure due to breakageand displacement. Drug strategies, such as the pill and Norplant™, whichrely on artificially controlling hormone levels, suffer from known andunknown side-effects from prolonged use. Finally, surgical procedures,such as tubal ligation and vasectomy, involve the costs and attendantrisks of surgery, and are frequently not reversible. Thus, there remainsa need for a safe, effective method of contraception, particularly anon-surgical method which is reversible.

SUMMARY OF THE INVENTION

The present invention is directed to a contraceptive or sterilizationsystem for occluding a reproductive tract or lumen to prevent thepassage of reproductive cells through the tract or lumen. The inventionincludes an occluding member expandable within the body lumen from afirst configuration suitable for introduction into the body lumen to asecond larger configuration to facilitate securing the expandedoccluding member to at least a portion of a wall which defines thereproductive body lumen. The invention also includes means to facilitatesecuring the expanded occluding member to the wall of the body lumen andmeans to contract the expanded occluding member and the wall portionsecured to the occluding member to occlude the reproductive body lumensufficiently to prevent the passage of reproductive cells therethrough.

One presently preferred embodiment of the invention comprises areversible contraceptive system which can be used to occlude either thefallopian tubes of a female patient, the vas deferens of a male patientor other reproductive tract. A key feature of the contraceptive systemis a occluding member which is first secured to the wall defining thereproductive tract in an expanded condition and then is collapsed tosmaller transverse cross-sectional dimensions to cause the collapse ofthe secured portion of the wall and thereby block the vessel passagewayto prevent the passage of reproductive cells. The occluding member maybe reopened by any number of suitable means. For example, by collapsingthe occluding member about a plug or mandrel which can be left in placeto effectively blocking the passageway until the patient wishes toreverse the procedure. The plug can be removed by suitable means such asconventional laparoscopic or other instruments to reopen the passageway.A balloon dilatation catheter may be used to further expand the openingonce the plug is removed Other ways of reopening the reproductive lumeninclude leaving the proximal portion of the occluding member open whenthe member is collapsed so that an expandable member such a balloon on acatheter can be inserted and expanded. By means of a series ofexpansions and stepped advancements, the entire passageway can bereopened.

Preferably, the occluding member comprises a tubular member formed froma shape-memory alloy material and has a primary configuration which isrelatively small in transverse dimensions to facilitate the insertion ofthe member into the desired body lumen. Once in place, the occludingmember is then expanded to a second configuration with transversedimensions roughly corresponding to or slightly larger than the bodylumen so that the occluding member can be secured to the wall definingthe body lumen. With the open, lattice-like framework of the occludingmember expanded within the body lumen, endothelialization through theopen structure secures the occluding member to the wall defining thebody lumen. By heating the occluding member formed of shape-memory alloymaterial to a temperature at or above the transition temperature of theshape-memory material, it transforms to a remembered closed or collapsedconfiguration which causes the wall secured to the occluding member toclose down so that the passageway therethrough is occluded. Theoccluding member may be delivered to the desired location within thebody lumen by suitable means such as a conventional balloon cathetersimilar to those used for delivering stents, aortic grafts and varioustypes of prosthesis.

In one presently preferred embodiment, the occluding member has an openor lattice-like framework so that the growth of endothelial tissuethrough the openings of lattice-like framework so as to interconnect theoccluding member and the wall of the body lumen. The surface of theoccluding member may be treated to promote the endothelialization.

Once the occluding member is implanted into the body lumen and it hasbeen sufficiently endothelialized to secure it to the body wall (whichmay take a week or more), it may be activated by warming the occludingmember to a temperature at or above the transition temperature of theshape-memory material so it may revert to its remember constrictedshape. Since the endotheliaization has secured the occluding member tothe wall of the body lumen, the contraction of the occluding member toits remembered collapsed shape, causes the wall defining the body lumento collapse along with the occluding member, effectively blocking thepassageway. Alternatively, a plug may be located within the interior ofthe occluding member prior to heat activation so that the occludingmember collapses onto the plug to block the lumen.

The occluding member may be mounted onto the exterior of a balloon of adilatation balloon catheter in the first configuration with smalltransverse dimensions, and then be introduced and positioned within theregion of the reproductive lumen to be occluded. The balloon is inflatedto expand the occluding member, preferably with the outer diameterslightly larger than the inner dimensions of the reproductive lumen towhich it is secured. The occluding member will remain in the openconfiguration until heated to a temperature at or above its martensiteto austenite transition temperature which causes it to revert to itscollapsed state. If the occluding member is collapsed about a plug, theplug may be extracted to reopen the passageway when the patient wishesto become fertile again.

The present invention provides effective sterilization or contraceptionfor both males and females and importantly it is easily reversed.Moreover, the implantation and activation of the occluding member aswell as the subsequent restoration of vessel patency requires easilyused minimally invasive devices such as catheters, guidewires, guidingcatheters and the like. These and other advantages of the invention willbecome more apparent from the following detailed description of theinvention when taken in conjunction with the accompanying exemplarydrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a catheter with an occluding member embodyingfeatures of the invention mounted on an expandable member on a distalsection of the catheter.

FIGS. 2 and 3 show one embodiment of the occluding member in expandedand contracted or closed configurations respectively.

FIGS. 4 and 5 show another embodiment of the occluding member inexpanded and closed configurations respectively.

FIGS. 6 and 7 show yet another embodiment of an occluding member inexpanded and closed configurations respectively.

FIG. 8 depicts the occluding member on a delivery catheter as shown inFIG. 1 within a reproductive tract or lumen.

FIG. 9 illustrates the expansion of the occluding member within thereproductive tract or lumen.

FIG. 10 illustrates the female reproductive anatomy and shows theoccluding member positioned within one of the patient's fallopian tubes.

FIG. 11 illustrates the male reproductive anatomy and depicts anexpanded occluding member within a vas deferens of a male patient.

FIG. 12 illustrates the occluding member secured to the wall of thereproductive tract by endothelial tissue.

FIG. 13 is a transverse cross-sectional view of the expandedendothelialized occluding member as shown in FIG. 12 taken along thelines 13-13.

FIG. 14 shows the occluding member in a collapsed state after beingactivated by warmed saline.

FIG. 15 is a transverse cross-sectional view of the collapsed occludingmember as shown in FIG. 14 taken along the lines 15-15.

FIG. 16 is similar to FIG. 14 and illustrates the occluding membercollapsed about an elongated removable plug or mandrel.

FIG. 17 shows the occluding member being activated in a location distalto the proximal extremity thereof in order to keep the proximal endpartially open to facilitate reopening the passageway.

FIG. 18 shows the occluding member being activated in a location distalto the proximal extremity thereof in order to keep the proximal endpartially open to facilitate reopening the passageway.

FIG. 19 shows an embodiment of the occluding member having hooks.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a catheter 10 useful in the practice of theinvention, which comprises an elongated shaft 12 having an inflationlumen 14 which is in fluid communication with inflatable member 16mounted on a distal section of the catheter shaft and adapter 18.Occluding member 20, a self-supporting metallic member of shape-memorymaterial, closely conforms to the diameter of the uninflated inflatablemember 16 to facilitate introduction into the desired body lumen.Occluding member 20 is formed so that it has a remembered collapsedconfiguration with relatively small transverse dimensions. The occludingmember 20 may be deformed to facilitate mounting onto the inflatablemember 16 and is expanded by the inflatable member to an open expandedconfiguration within a body lumen. Upon heating to a transitiontemperature it will revert to the remembered configuration. In thisembodiment the occluding member 20 has an open, lattice-type structurefacilitating endothelialization which secures the occluding member tothe wall defining the body lumen. Preferably, occluding member 20 can bedeformed to an expanded diameter, preferably equal to or slightly largerthan the dimensions of the body lumen within which the occluding memberis to be disposed. For disposition within a female patient's fallopiantubes the expanded transverse dimensions should be about 0.1 mm to about5 mm.

The occluding member may have a number of suitable configurations asshown in schematically in FIGS. 2-7. FIGS. 2 illustrates occludingmember 22 in an open configuration and FIG. 3 its relatively smalldimensioned configuration for introduction and advancement into thepatient's body lumen. Occluding member 22 may be constructed from alength of shape memory hypodermic tubing. Slots 24 cut into the wall ofthe tubing allow expansion of the occluding member into an openconfiguration as shown in FIG. 2. Likewise, in FIGS. 4 and 5, occludingmember 26 is a coil 28 of shape-memory wire or ribbon. FIGS. 6 and 7show occluding member 30, which comprises a braided tube of shape-memorywire or ribbon 32. Finally, in FIGS. 1 and 8 occluding member 20comprises a number of closed sinusoidal rings of shape-memory wire orribbon and is mounted onto an inflatable member 16 of catheter 10.

Inflation of inflatable member 16 expands occluding member 20 in areproductive tract 38 to an open, relatively large diameterconfiguration as shown in FIG. 9.

In each of these embodiments, the shape memory material of the occludingmember should have a transition temperature sufficiently above thenormal variation of human body temperature to prevent accidentalactivation which might prematurely collapse the occluding member. On theother hand, the transition temperature should be high enough so thatthermal activation of the occluding member does not cause undesirablethermal damage to the surrounding tissue. The shape memory-material ispreferably a shape memory, nickel-titanium alloy such as NITINOL andpreferably has a transition temperature of between about 43.degree. C.to about 70.degree. C.

In each of the embodiments described above, certain conventionalrefinements may be employed. For example, the surface of the occludingmember's framework may be designed to facilitate endothelial growth.Such modifications generally comprise providing the occluding memberwith an open or lattice-like framework to promote endothelial growthinto as well as around the member to ensure it secure attachment to thewall of the body lumen. Suitable surface techniques include EDMmachining, laser drilling, photo etching, scintering and the like.Additionally, increasing the surface area of the occluding member canalso provide greater adhesion for the endothelial tissue. Suitablesurface treatments include plasma etching, sand blasting, machining andother treatments to roughen the surface. In other embodiments, theshape-memory material may be coated or seeded to spurendothelialization. For example, the occluding device can be coated witha polymer having impregnated therein a drug, enzyme or protein forinducing or promoting endothelial tissue growth. In yet anotherrefinement, the occluding member could be plated with or otherwiseincorporate copper to produce an inflammatory response in the tissue ofthe wall defining the body lumen, which further contributes to theobstruction of the lumen. Other inflammatory materials my be suitable aswell. For example, the occluding member could be radioactive, emittingalpha, beta or gamma particles.

The practice of the invention comprises the following general steps. Anoccluding member 20 having relatively small transverse dimension ismounted onto the exterior of balloon 16 of catheter 10 as shown inFIG. 1. The catheter 10 is advanced under fluoroscopic or endoscopicvisualization until occluding member 20 is positioned within one of thefemale patient's fallopian tubes 34, as shown in FIG. 10. Inflationfluid is introduced through adapter 18 to inflate inflatable member 16.As shown in FIGS. 9-10, inflation of inflatable member 16 expandsoccluding member 20 to an open configuration and lodging it in bodylumen 38. Catheter 10 is removed, leaving the expanded occluding member20 implanted in body lumen 38 as shown in FIG. 12. Another expandablemember is delivered to the patient's other fallopian tube and expandedtherein in the same manner. Alternatively, the occluding member may beexpanded into positioned within the vas deferens 36 of a male patient asshown in FIG. 11 to provide male contraception using the sameprocedures.

Over a period of a week or more endothelial cells lining the lumen willproliferate; growing around the open framework of occluding member 20 asshown in FIGS. 12 and 13 thereby securing the wall defining the bodylumen 38 to the expanded occluding member 20. After the expandedoccluding member 20 is sufficiently endothelialized within the patient'sreproductive tract 38, it is thermally activated to return it to itsremembered collapsed configuration. The occluding member may beactivated by several means, including warmed fluid, RF energy, laserenergy, or other suitable energy sources. A suitable activation systemis shown in FIG. 14 where the distal end of catheter 40 is positionedadjacent to the occluding member 20, saline fluid somewhat above thetransition temperature is introduced to bathe occluding member 20,raising its temperature to the transition point or higher, causingoccluding member 20 to collapse to its closed, reduced-diameterconfiguration. The layer of endothelial tissue that forms within thelattice-like structure of the occluding member helps block and seal thelumen so as to prevent the passage of reproductive cells, eggs or spermcells.

In an alternative embodiment of the invention is shown in FIG. 16 wherea plug 42 is positioned inside occluding member 20 in the expandedcondition so that upon activation the occluding member 20 collapses ontoplug 42, blocking the lumen 38. The plug is preferably formed from aninert material such as a fluoropolymer, e.g. PTFE. Other suitablematerials include high density polyethylene and silicone rubber. Anumber of modifications to the plug may also be suitable. For example,the plug could be used as a drug delivery device, similar to theNorplant.™. device. The plug could also be used to provoke aninflammatory response as described above to augment the occlusion of thelumen. In such embodiments, plug 42 preferably has an outer diameterfrom about 0.25 mm to about 4 mm. The plug 42 may also have holes, deepgrooves. or which help to preserve at least part of the natural liningof the reproductive tract.

The occlusion of the lumen may be reversed simply by removing the plug42. If a passageway larger than passageway left by the removed plug 42is desired, a balloon catheter can be advanced within the body lumenuntil the balloon is within the lumen left by the removal of the plugand then the balloon on the catheter is inflated to expanded theoccluding member 20, deforming it into an open configuration. It may bedesirable when activating the expanded occluding member to the collapsedconfiguration to leave the proximal end of the occluding member somewhatopen or in an expanded condition to facilitate the introduction ofdilatation balloon on a catheter to facilitate the opening of the bodylumen. As shown in FIG. 15, the catheter 40 used to activate theoccluding member may be positioned within the proximal end of theoccluding member, so that the proximal end is unable to completelyrevert to its closed configuration. The reproductive tract could besubsequently close should contraception again be desired by heating theoccluding member 20 so as to activate the transformation thereof to thecollapsed configuration.

In embodiments of the invention employing the plug 40, various otherstrategies are suitable to reverse the occlusion. For example, the plug40 can simply be removed, restoring the lumen 38 to patency.Alternatively, the plug 40 may be hollow with a removable core (notshown). This core may be formed from a softer material, such assilicone, or could be threaded, in order to facilitate its removal.Similarly, the plug itself may be threaded so that removal wouldcomprise a twisting motion, minimizing the stress on the tissue in whichthe occluding member is located.

In still other embodiments, mechanical, adhesive or other means may beemployed to secure the expanded occluding member 20 to the vessel walldefining the reproductive passageway 38. For example, the means tosecure a stent or prosthetic device to an aortic or arterial walldescribed in U.S. Pat. Nos. 4,140,126; 4,562,596; 4,577,631; 4,787,899;5,104,399; 5,167,614; 5,275,622; 5,36,713; and 5,489,295 may be usedwith the present invention to interconnect the wall defining thereproductive tract and the expandable member. These patents areincorporated herein in their entireties by reference.

Various modifications and improvements may be made to the presentinvention without departing from the scope thereof. For example, amechanical expandable member such as described in U.S. Pat. No.4,585,000, which is incorporated herein by reference, may be used toexpand the expandable member within the reproductive tract to engage thewall thereof. Moreover, although individual features of embodiments ofthe invention may be shown in some of the drawings and not in others,those skilled in the art will recognize that individual features of oneembodiment of the invention can be combined with any or all the featuresof one or more of the other embodiments.

We claim:
 1. A contraceptive system for occluding a reproductive bodylumen to prevent the passage of reproductive cells therethrough,comprising: a) an occluding member, said occluding member being at leastin part expandable within the reproductive body lumen from a firstconfiguration to a second expanded configuration, wherein a surface ofthe occluding member is roughened, coated or seeded to spur ingrowth oftissue cells and secure a wall portion of the reproductive body lumenthereto when in the second expanded configuration; b) means to collapsethe expanded part of the occluding member to a smaller transversecross-sectional dimension so that the wall portion secured theretocollapses thereupon to occlude the reproductive body lumen sufficientlyto prevent the passage of reproductive cells therethrough.
 2. Thecontraceptive system of claim 1, wherein said occluding member is atleast in part radially expandable about a longitudinal axis thereof fromsaid first configuration to said second expanded configuration andfurther provided with a deliverable contraceptive agent.
 3. Thecontraceptive system of claim 2 wherein the contraceptive agent is ahormone.
 4. The contraceptive system of claim 3 wherein thecontraceptive hormone is progestin.
 5. The contraceptive system of claim1 wherein the occluding member is a tubular member with an openframework in the expanded configuration that facilitates said ingrowthof tissue cells.
 6. The contraceptive system of claim 5 wherein thetubular member is formed of a thin walled metallic tube having a patternof openings configured to allow the tubular member to be expanded to theopen framework.
 7. The contraceptive system of claim 6 wherein thetubular member has an inner lumen.
 8. The contraceptive system of claim7 wherein an inner member is disposed within the inner lumen of thetubular member.
 9. The contraceptive system of claim 8 wherein thecontraceptive hormone is incorporated in the inner member.
 10. Thecontraceptive system of claim 5 wherein the tubular member is formed ofa helical wire configured to allow the tubular member to be expanded tothe open framework.
 11. The contraceptive system of claim 5 wherein thetubular member is formed of a braided wire tube configured to allow thetubular member to be expanded to the open framework.
 12. Thecontraceptive system of claim 1 including an expanding means to expandat least a portion of the occluding member.
 13. The contraceptive systemof claim 12 wherein the expanding means is an elongated catheter havingan inner lumen extending within the elongated catheter from a proximalportion of the catheter to a location within a distal portion, aninflatable member on a distal portion thereof with an interior in fluidcommunication with the inner lumen to facilitate the delivery ofinflation fluid to the interior of the inflatable member.
 14. Thecontraceptive system of claim 1 including a mandrel configured to bedisposed within an expanded part of the occluding member so that theoccluding member contracts onto the mandrel to occlude the reproductivebody lumen sufficiently to prevent the passage of reproductive cellstherethrough.
 15. The contraceptive system of claim 1 wherein theoccluding member has a tubular open-wall structure which facilitates theingrowth of tissue cells thereinto thereby securing the expanded part ofthe occluding member to the wall portion.
 16. The contraceptive systemof claim 15 wherein the tubular structure has an lattice-like framework.17. The occluding member of claim 16 wherein the lattice-like frameworkcomprises a thin walled metallic tube having a pattern of cutsconfigured to allow the occluding member to be expanded to anopen-walled, relatively large diameter configuration.
 18. Thecontraceptive system of claim 1 wherein the occluding member includesstructure that prevents it from being readily removable from thereproductive body lumen.
 19. A contraceptive device for deployment in afemale patient's fallopian tube, comprising:(a) a tubular body which isat least in part radially expandable about a longitudinal axis thereofwithin the patient's fallopian tube from a first transverse dimension toa second larger transverse dimension and which has an open framework inthe expanded configuration that facilitates an ingrowth of tissue cells,wherein a surface of the tubular body is roughened, coated or seeded tospur said ingrowth of tissue cells and secure a wall portion of thefallopian tube thereto when in the second larger transverse dimension;and(b) an inner member within the tubular body which delivers a femalecontraceptive hormone.
 20. The contraceptive device of claim 19 whereinthe tubular body is of cylindrical shape.
 21. The contraceptive deviceof claim 19 wherein the contraceptive hormone is progestin.
 22. Acontraceptive device for deployment in a female patient's fallopiantube, comprising:(a) a tubular body which is at least in part radiallyexpandable about a longitudinal axis thereof within the patient'sfallopian tube from a first transverse dimension to a second largertransverse dimension and which has an open framework in the expandedconfiguration facilitating ingrowth of tissue cells, wherein a surfaceof the tubular body is roughened, coated or seeded to spur said ingrowthof tissue cells and secure a wall portion of the fallopian tube theretowhen in the second larger transverse dimension; and(b) means within thetubular body to deliver a female contraceptive hormone.
 23. Thecontraceptive device of claim 22 wherein the contraceptive hormone isprogestin.
 24. A contraceptive device comprising an intraluminalocclusion means which is at least in part radially expandable about alongitudinal axis thereof within a lumen of a patient's reproductivesystem from a transverse dimension to a second larger transversedimensions and which facilitates the ingrowth of tissue cells, wherein asurface of the intraluminal occlusion means is roughened, coated orseeded to spur said ingrowth of tissue cells and secure a wall portionof the lumen thereto when in the second larger transverse dimension andis provided with a deliverable contraceptive agent.
 25. A contraceptivedevice for deployment in a female patient's fallopian tube,comprising:(a) a tubular body which is at least in part radiallyexpandable about a longitudinal axis thereof within the patient'sfallopian tube from a first transverse dimension to a second largertransverse dimension and which has an open framework in the expandedconfiguration facilitating ingrowth of tissue cells, wherein a surfaceof the tubular body is roughened, coated or seeded to spur said ingrowthof tissue cells and secure a wall portion of the fallopian tube theretowhen in the second larger transverse dimension; and(b) a member attachedto the tubular body which delivers a female contraceptive hormone. 26.The contraceptive device of claim 25 wherein the contraceptive hormoneis progestin.
 27. The contraceptive device of claim 25 wherein themember is porous.
 28. The contraceptive device of claim 25 wherein themember is at least in part within the lumen of the tubular body.
 29. Thecontraceptive device of claim 25 wherein the member is configured toprovoke an inflammatory response.
 30. The contraceptive device of claim29 wherein the member is formed at least in part of a material whichprovokes an inflammatory response.
 31. The contraceptive device of claim30 wherein the material is copper.
 32. An occluding assembly comprisingan occluding member having a tubular metallic framework with an innerlumen extending therein and including a plug positioned within thelumen, the plug comprising a hollow tube and removable core, wherein theoccluding member has a closed configuration about the plug disposedwithin the inner lumen thereof, so that the occluding member may beexpanded to an open, relatively larger diameter configuration by removalof the plug, and then may be heated to the transition temperature tocause the occluding member to revert to the closed configuration, andwherein the tubular metallic framework comprises an open frameworkfacilitating ingrowth of tissue cells, and wherein a surface of thetubular metallic framework is roughened, coated or seeded to spur saidingrowth of tissue cells and secure a wall portion of the fallopian tubethereto when in the relatively larger diameter configuration.
 33. A kitfor performing a reversible sterilization procedure comprising;(a) acatheter having an inflatable member; and(b) an occluding membercomprising a tubular metallic framework which has a closed, smallerconfiguration and is formed from a shape-memory material having atransition temperature above body temperature, so that the occludingmember may be expanded to an open, relatively larger diameterconfiguration, and then heated to or above the transition temperature tocause the occluding member to revert to the closed, smaller diameterconfiguration within a body lumen, the occluding member furthercomprising a plug configured to be positioned therewithin, wherein theplug is provided with one or more depressions or grooves to minimizedamage to tissue lining of the body lumen, wherein the tubular metallicframework comprises an open framework facilitating ingrowth of tissuecells, and wherein a surface of the tubular metallic framework isroughened, coated or seeded to spur said ingrowth of tissue cells andsecure a wall portion of the body lumen thereto when in the open,relatively larger diameter configuration.
 34. A contraceptive devicecomprising: an open-walled tubular member capable of being introducedwithin a portion of a fallopian tube, wherein a surface of the tubularmember is roughened, coated or seeded to spur ingrowth of tissue cellsand secure a wall portion of the fallopian tube thereto. and anocclusive member within said tubular member, wherein occlusion of thefallopian tube is augmented by said ingrowth into said occlusive member.35. The contraceptive device of claim 34 wherein the tubular member isformed of a shape-memory alloy.
 36. The contraceptive device of claim 35wherein the shape memory alloy of the tubular member has a firstsmall-dimensioned stable martensite phase at body temperature,facilitating the introduction thereof into said lumen of said fallopiantube, is expandable to a second larger configuration to facilitate saidsecuring of the tubular member to the lumen of said portion of fallopiantube, and has a contracted remembered shape in an austenite phase attemperatures higher than body temperature with the rememberedconfiguration having smaller transverse dimensions than the secondlarger configuration.
 37. The contraceptive device of claim 36 whereinthe tubular member has incorporated therein or coated thereon a drug orother therapeutic agent.
 38. A contraceptive device for occluding afallopian tube having an inner diameter and an outer diameter whereinthe fallopian tube defines a lumen lined by an epithelial layer, thedevice comprising a tubular member capable of being introduced into thelumen of the fallopian tube, wherein a surface of the tubular member isroughened, coated or seeded to spur ingrowth of the epithelial layer andsecure the epithelial layer thereto, and an occlusive body within thetubular member comprising a radioactive material to provoke aninflammatory response in the fallopian tube.
 39. The contraceptivedevice of claim 38, wherein the application of heat is selected from thegroup consisting of warm fluid, radio frequency energy, laser energy andcombinations thereof.
 40. The contraceptive device of claim 39 whereinthe tubular member is maintained in the reduced diameter portion of thefallopian tube for sufficient time to allow tissue ingrowth thereinto.41. The contraceptive device of claim 38 wherein the tubular member hasan open-wall structure that promotes said in-growth of the epitheliallayer.
 42. The contraceptive device of claim 41, wherein occlusion ofthe fallopian tube is augmented by said ingrowth.
 43. The contraceptivedevice of claim 38 wherein the radioactive material is selected from thegroup consisting of an alpha particle emitter, a beta particle emitter,a gamma particle emitter and combinations thereof.
 44. The contraceptivedevice of claim 38 wherein the occlusive body includes grooves.
 45. Thecontraceptive device of claim 38 wherein the occlusive body includesholes.
 46. The contraceptive device of claim 38 wherein the occlusivebody has incorporated therein or coated thereon a drug or othertherapeutic agent.
 47. The contraceptive device of claim 46 wherein thetherapeutic agent is a growth hormone that promotes the tissue ingrowthof the endothelial layer.
 48. An occluding member for occluding a lumen,the occluding member comprising: an open-walled structure; an occlusiveplug comprising silicone within the open-walled structure; and wherein asurface of the occluding member is roughened, coated or seeded to spuringrowth of tissue cells into the occluding member.
 49. The occludingmember of claim 48 wherein the surface is coated with a polymer coating.50. The occluding member of claim 49 wherein the polymer coating isimpregnated with a drug, enzyme or protein.
 51. The occluding member ofclaim 48 wherein the surface is seeded.